SPL v3
SPL
SPL Set ID 227a8e50-e79d-0e9c-e063-6394a90a4a21
Route
DENTAL
Published
Effective Date 2024-07-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.243 g)
Inactive Ingredients
Xylitol Hydrated Silica Glycerin Pentylene Glycol Caprylyl Glycol Xanthan Gum Carboxymethylcellulose Sodium, Unspecified Form Benzoic Acid Menthol Sucralose Sodium Gluconate Titanium Dioxide Methyl Diisopropyl Propionamide Sodium Phosphate, Dibasic, Anhydrous Sorbitol Water Zinc Lactate Benzyl Alcohol Sodium Lauroyl Sarcosinate Potassium Pyrophosphate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-23

Description

Sodium Fluoride 0.243% (0.14 w/v fluoride ion)

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium Fluoride 0.243% (0.14 w/v fluoride ion)

Use

Aids in the prevention of dental cavities

Label

Directions

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).

Supervise children as necessary until capable of using without supervision.

Children under 2 years of age: Consult a dentist or doctor.

Active Ingredient

Sodium Fluoride 0.243%

(0.14 w/v fluoride ion)

Inactive Ingredients

Water

Sorbitol

Hydrated Silica

Glycerin

Xylitol

Disodium Phosphate

Sucralose

Sodium Lauroyl Sarcosinate

Xanthan Gum

Cellulose Gum

Flavor

Tetrapotassium Pyrophosphate

Caprylyl Glycol

Benzyl Alcohol

Menthol

Sodium Gluconate

Pentylene Glycol

Zinc Lactate

Benzoic Acid

Methyl Diisopropyl Propionamide

Titanium Dioxide

When Using This Product

Do not swallow

Do not use in eye area

Keep Out of the Reach of Children Under 6 Years of Age

If more than used for brushing is swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use

Aids in the prevention of dental cavities

Label (label)

Purpose

Anticavity

Directions

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).

Supervise children as necessary until capable of using without supervision.

Children under 2 years of age: Consult a dentist or doctor.

Active Ingredient (Active ingredient)

Sodium Fluoride 0.243%

(0.14 w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

Water

Sorbitol

Hydrated Silica

Glycerin

Xylitol

Disodium Phosphate

Sucralose

Sodium Lauroyl Sarcosinate

Xanthan Gum

Cellulose Gum

Flavor

Tetrapotassium Pyrophosphate

Caprylyl Glycol

Benzyl Alcohol

Menthol

Sodium Gluconate

Pentylene Glycol

Zinc Lactate

Benzoic Acid

Methyl Diisopropyl Propionamide

Titanium Dioxide

When Using This Product (When using this product)

Do not swallow

Do not use in eye area

Keep Out of the Reach of Children Under 6 Years of Age (Keep out of the reach of children under 6 years of age)

If more than used for brushing is swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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